Article, 2024

Evolut PRO and SAPIEN ULTRA Performance in Small Aortic Annuli The OPERA-TAVI Registry

JACC Cardiovascular Interventions, ISSN 1876-7605, 1936-8798, Volume 17, 5, Pages 681-692, 10.1016/j.jcin.2024.01.006

Contributors

Scotti, Andrea 0000-0003-4731-4384 [1] [2] Sturla, Matteo 0000-0002-1096-962X [1] [2] Costa, Giuliano [3] Saia, Francesco 0000-0001-9969-2649 [4] [5] Pilgrim, Thomas [6] Abdel-Wahab, Mohamed [7] Garot, Philippe [8] Gandolfo, Caterina 0000-0001-6049-8961 [9] Branca, Luca [10] Santos, Ignacio Amat [11] Mylotte, Darren M 0000-0001-7824-2577 [12] Bedogni, Francesco 0000-0002-4975-6605 [13] De Backer, Ole 0000-0002-9674-0278 [14] Nombela-Franco, L N F 0000-0003-3438-8907 [15] Webb, John [16] Ribichini, Flavio Luciano 0000-0002-6662-0304 [17] Mainardi, Andrea [17] Andreaggi, Stefano 0009-0007-6115-5822 [17] Mazzapicchi, Alessandro [4] [5] Tomii, Daijiro 0000-0002-4488-1335 [6] Laforgia, Pietro [8] Cannata, Stefano 0000-0002-0559-7833 [9] Fiorina, Claudia 0000-0001-7868-1617 [10] Fezzi, Simone 0000-0003-2755-2094 [12] Criscione, Enrico 0000-0002-1550-8531 [13] Lunardi, Mattia 0000-0001-8344-6048 [17] Poletti, Enrico 0000-0002-3605-505X [13] Mazzucca, Mattia [13] Quagliana, Angelo 0000-0001-7024-3452 [14] Montarello, Nicholas J [14] Hennessey, Breda 0000-0002-0420-943X [15] Mon-Noboa, Matias [15] Akodad, Myriam [18] Meier, David 0000-0002-5524-5844 [19] [20] De Marco, Federico [21] Adamo, Marianna [10] Sgroi, Carmelo [3] Reddavid, Claudia Maria [3] Valvo, Roberto [13] Strazzieri, Orazio 0000-0003-2971-363X [3] Motta, Silvia Crescenzia [3] Frittitta, Valentina [3] Dipietro, Elena [3] Comis, Alessandro [3] Melfa, Chiara [3] Calì, Mariachiara [3] Sammartino, Sofia [3] Laterra, Giulia [20] [22] Thiele, Holger [7] Sondergaard, Lars [14] Tamburino, Corrado [3] Barbanti, Marco 0000-0002-4903-5437 [23] Latib, Azeem Mohamed 0000-0001-9035-343X (Corresponding author) [1] [2]

Affiliations

  1. [1] Albert Einstein College of Medicine
    2. [NORA names: United States; America, North; OECD];
  2. [2] Montefiore Medical Center
    3. [NORA names: United States; America, North; OECD];
  3. [3] Division of Cardiology, A.O.U. Policlinico "G. Rodolico-San Marco," Catania, Italy.
    4. [NORA names: Italy; Europe, EU; OECD];
  4. [4] Policlinico S.Orsola-Malpighi
    5. [NORA names: Italy; Europe, EU; OECD];
  5. [5] University of Bologna
    6. [NORA names: Italy; Europe, EU; OECD];

Abstract

BACKGROUND: The performance of latest iteration transcatheter aortic valve replacement platforms in patients with small aortic anatomy remains underexplored. OBJECTIVES: The aim of this study was to evaluate effectiveness and performance between the self-expanding (SE) Evolut PRO and PRO+ and the balloon-expandable (BE) SAPIEN ULTRA in patients with small aortic annuli. METHODS: Data from the OPERA-TAVI (Comparative Analysis of Evolut PRO vs. SAPIEN 3 ULTRA Valves for Transfemoral Transcatheter Aortic Valve Implantation) registry were used, with 1:1 propensity score matching. Primary endpoints included 1-year effectiveness composite (all-cause mortality, disabling stroke, or heart failure hospitalization) and 30-day device-related (hemodynamic structural valve dysfunction and nonstructural valve dysfunction) outcomes. RESULTS: Among 3,516 patients, 251 matched pairs with aortic annular area <430 mm2 were assessed. The 1-year primary effectiveness outcome did not differ significantly between cohorts (SE 10.8% vs BE 11.2%; P = 0.91). The 30-day device-oriented composite outcome was more favorable in the Evolut PRO group (SE 4.8% vs BE 10.4%; P = 0.027). Notably, SE valve recipients showed higher rates of disabling stroke (SE 4.0% vs BE 0.0%; P < 0.01) and paravalvular leaks (mild or greater: SE 48.5% vs BE 18.6% [P < 0.001]; moderate: SE 4.5% vs BE 1.2% [P = 0.070]). The BE group had higher rates of prosthesis-patient mismatch (moderate or greater: SE 16.0% vs BE 47.1% [P < 0.001]; severe: SE 1.3% vs BE 5.7% [P = 0.197]) and more patients with residual mean gradients >20 mm Hg (SE 1.0% vs BE 13.5%; P < 0.001). CONCLUSIONS: In patients with small aortic annuli, transcatheter aortic valve replacement with latest iteration devices is safe. SE platforms are associated with more favorable device performance in terms of hemodynamic structural and nonstructural dysfunction. Randomized data are needed to validate these findings and guide informed device selection.

Keywords

Annuli, BE group, Evolut PRO, ITER device, PRO group, SE platforms, Ultra, Ultra-Performance, anatomy, annular area, annulus, aortic anatomy, aortic annular area, aortic annulus, aortic valve replacement, area, cohort, composite outcome, composition, data, device performance, device selection, device-related, devices, disabling stroke, dysfunction, effect, effective composition, effective outcomes, endpoint, evaluate effects, evolution, findings, gradient, group, iteration, leak, matching, mean gradient, mismatch, nonstructural dysfunction, outcomes, pairs, paravalvular leak, patients, performance, platform, primary endpoint, propensity, propensity score matching, pros, prosthesis-patient mismatch, random data, rate, rate of disabling stroke, rates of prosthesis-patient mismatch, recipients, registry, replacement, residual mean gradient, sapiens, score matching, selection, self-expanding, small aortic annulus, stroke, study, transcatheter, transcatheter aortic valve replacement, valve recipients, valve replacement

Funders

  • Edwards Lifesciences (United States)

Data Provider: Digital Science

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